ANDA 204980

GLENMARK PHARMS LTD

FDA Drug Application

Application #204980

Application Sponsors

ANDA 204980

GLENMARK PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;ORAL

10MG/ML

0

LACOSAMIDE

LACOSAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-03-17

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204980
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LACOSAMIDE","activeIngredients":"LACOSAMIDE","strength":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-17
        )

)